The present invention relates to an apparatus and method for use in pre-screening or determining the adequacy of target cells in a specimen prior to conducting further diagnostic testing or analysis of the specimen. More specifically, the present invention concerns a device and method which uses light scatter techniques to detect the presence of a target cell in a specimen.
Prior to conducting an analysis or testing of a cell specimen, it is important to insure that an adequate amount of target cells are present in the specimen. This is particularly true with respect to pap smear specimens.
It is estimated that about 180 million pap smears are performed in the United States annually with an estimated 33% of all specimens originally collected containing insufficient target cellsxe2x80x94ectocervical or squamous cells. This results in an inability to properly analyze the specimen and in a tremendous loss in time and money. Typically, not only must a patient reschedule another office visit to provide a second specimen, a second charge is often incurred to obtain the second specimen with no guarantee that enough target cells were again obtained. Thus, there is a need to provide a method and apparatus which provides a quick and efficient system to pre-screen specimens to determine if adequate target cells are present.
The present invention solves this lack of pre-screening by providing a device and method which analyzes a specimen through the use of submitting the specimen to a light scatter analysis. Through this technique, a specimen may be analyzed for the presence of sufficient quantities of a target cell. In addition, the technique would also allow a specimen to be analyzed for the presence of target cells which may adversely affect the diagnostic procedure to be used.